Regulatory Affairs Manager

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Regulatory Affairs Manager

Apply locations Indonesia - Pondok Indah time type Full time posted on Posted 23 Days Ago job requisition id 31111962

JOB DESCRIPTION:

Responsibilities

As the Specialist in the Regulatory Affairs Sub-Function, considered as highly experienced and knowledgeable resource within the organization in directing development of product registration submission, progress reports, supplements, amendments, or periodic experience reports.

• Interacts with regulatory agency to expedite approval of pending registration.
• Serves as regulatory liaison throughout product lifecycle.
• Participates in product plan development and implementation, regulatory strategy, risk management, chemistry manufacturing control (CMC).
• Ensures timely approval of new drugs, biologics or medical devices and continued approval of marketed products.
• Serves as regulatory representative to marketing, research teams and regulatory agencies.
• Advises development and/or marketing teams on manufacturing changes, line extensions, technical labeling, appropriate regulations and interpretations.
• Engages in regulation discussions with government and associations.
• Analyzes the product and assesses the formula.
• Provides recommendations for next actions.
• Reviews implications of new or revised regulations on the ANI's products.
• Provides assessments.
• Inputs to the RPI system.
• Gives input for new/revised regulations to BPOM as Abbott or through trade associations.
• Provides input about Abbott's positioning and concerns.
• Attends regulatory socialization as a member of trade associations.
• Conducts advocacy through associations for concerns that may impact Abbott.
• Engages with BPOM together with trade associations.
• Submits and obtains approval for products in a timely manner.
• Collaborates with MKT and Global to prepare registration documents and packaging.
• Reviews PMRA according to regulations.
• Gives input or recommendations for communication materials.
• Updates on progress and trends.
• Initiates and arranges meetings with KOL and BPOM.
• Submits petitions with appropriate supporting data.
• Reviews and assesses formulas.
• Provides input for business decisions - sharing regulations with related parties.
• Participates with other departments.
• Shares knowledge with regulators.

Requirements

• Minimal Bachelor in Food Technology/Pharmacy.
• Expert in Food Registration, HACCP, Food Standardization, Halal Food, CODEX.
• Minimum 10 years' experience in Food Regulatory Environment (Registration Submission, Ijin Khusus, etc).
• Expert in Food Regulation (Indonesia and Overseas).

The base pay for this position is N/A. In specific locations, the pay range may vary from the range posted.

JOB FAMILY:

Regulatory Operations

DIVISION:

AN Abbott Nutrition

LOCATION:

Indonesia > Pondok Indah : Wisma Pondok Indah 2

ADDITIONAL LOCATIONS:

WORK SHIFT:

Standard

TRAVEL:

No

MEDICAL SURVEILLANCE:

Not Applicable

SIGNIFICANT WORK ACTIVITIES:

Not Applicable

About Us

Abbott is about the power of health. For more than 135 years, Abbott has been helping people reach their potential — because better health allows people and communities to achieve more. With a diverse, global network serving customers in more than 160 countries, we create new solutions — across the spectrum of health, around the world, for all stages of life. Whether it’s next-generation diagnostics, life-changing devices, science-based nutrition, or novel reformulations, we are advancing some of the most innovative and revolutionary technologies in healthcare, helping people live their best lives through better health.

The people of Abbott come to work each day with relentless energy, enthusiasm and a promise to enhance the health and well-being of millions of people. They push the boundaries to help manage and treat some of life’s greatest health challenges.

We invite you to explore opportunities at Abbott, to see if your talents and career aspirations may fit with our openings. An equal opportunity employer, Abbott welcomes and encourages diversity in our workforce.